U.S. patent application number 14/142555 was filed with the patent office on 2014-04-24 for surgical hand piece with dual lumen work tip for use with infusion cannula.
This patent application is currently assigned to Surgical Design Corporation. The applicant listed for this patent is Surgical Design Corporation. Invention is credited to William Banko.
Application Number | 20140114335 14/142555 |
Document ID | / |
Family ID | 50486004 |
Filed Date | 2014-04-24 |
United States Patent
Application |
20140114335 |
Kind Code |
A1 |
Banko; William |
April 24, 2014 |
SURGICAL HAND PIECE WITH DUAL LUMEN WORK TIP FOR USE WITH INFUSION
CANNULA
Abstract
A surgical hand piece has a source of ultrasonic energy provided
to a connecting body having a first passage with one end to receive
fluid from a first source and the other end at the connecting body
distal end. A work tip has first and second tubes each having at
least one opening at its distal end and the proximal end of one or
both of the tubes connected to the connecting body distal end to
receive the ultrasonic energy and to selectively receive or
discharge fluid from either the first or second source as
controlled by a valve. A cannula is provided which is adapted to be
placed in an opening in the cornea through which the work tip
extends during the removal of cataracts from the eye by
phacoemulsification. The cannula may be equipped with channels that
permit additional infusion of fluid into the eye during the
procedure, which infusion also cools the surrounding corneal tissue
to protect against heat generated by the ultrasonic vibration of
the work tip.
Inventors: |
Banko; William; (Armonk,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Surgical Design Corporation |
Armonk |
NY |
US |
|
|
Assignee: |
Surgical Design Corporation
Armonk
NY
|
Family ID: |
50486004 |
Appl. No.: |
14/142555 |
Filed: |
December 27, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12215315 |
Jun 26, 2008 |
8641658 |
|
|
14142555 |
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Current U.S.
Class: |
606/169 |
Current CPC
Class: |
A61B 2217/007 20130101;
A61B 2017/320084 20130101; A61B 2217/005 20130101; A61F 9/00745
20130101; A61M 1/0064 20130101; A61B 17/3421 20130101 |
Class at
Publication: |
606/169 |
International
Class: |
A61B 17/32 20060101
A61B017/32; A61M 1/00 20060101 A61M001/00 |
Claims
1. A surgical hand piece comprising: a source of ultrasonic energy;
a connecting body having a proximal end connected to said
ultrasonic energy source and a distal end; and a work tip having a
proximal hub from which extend at least first and second tubes
aligned side by side and adjacent to each other, said hub having
first and second external openings, each of said tubes having a
proximal end connected to separate passages in said hub leading to
the external openings, said work tip being detachably connected to
said connecting body distal end and being of a material suitable
for conveying the ultrasonic energy from said ultrasonic energy
source to the distal end of said at least one tube, wherein each of
said first and second tubes has a lumen that is to receive or
discharge a fluid at its proximal end from one of first and second
fluid sources that are respectively irrigation and aspiration
fluids, the lumen of each of said first and second tubes being
separate and spaced apart, and each said tube having an opening at
its distal end through which the fluid received at or discharged
from the proximal end of the respective lumen of each said tube
exits from or enters the tube, with each said tube distal end
opening being separate, independent of, spaced from and without
being in communication with the distal end opening of the other
tube.
2. The surgical hand piece according to claim 1 wherein the first
and second external openings are on opposite sides of the hub and
are at an angle to the respective tubes.
3. The surgical hand piece according to claim 1 further including a
valve to receive the fluids from the first source and discharge
fluid to the second source and for switching the received and
discharged fluids respectively to be supplied to or received from
the respective lumen of either one of said first and second tubes,
wherein the respective lumen of each of said first and second tubes
can receive or discharge the fluid from either one of said first
and second sources as switched by said valve.
4. The surgical hand piece according to claim 1 further including a
housing that covers the source of ultrasonic energy and the
connecting body, but not the work tip; and wherein the work tip is
detachable from the connecting body while leaving the connecting
body attached to said source of ultrasonic energy, and the work tip
is designed to be disposed after a single use.
5. The surgical hand piece according to claim 4 wherein a core of
the proximal hub as well as the first and second tubes are made of
titanium, and the portion of the hub surrounding the core, the
separate passages in the hub and the external connectors are made
of a hard plastics material.
6. The surgical hand piece according to claim 4 wherein the
external openings are connectors.
7. The surgical hand piece according to claim 4 further including
disposable tubes inserted into the passages in said hub that mate
with respective ones of the first and second tubes.
8. The surgical hand piece according to claim 7 wherein the
disposable tubes are made of plastic, the proximal ends of the
tubes have sealing openings and the plastic protrudes through the
sealing openings.
9. The surgical hand piece according to claim 7 wherein the
disposable tubes have connectors at their ends.
10. The surgical hand piece according to claim 1 wherein one of the
at least first and second tubes has a distal opening that is larger
than the distal opening of the other.
11. The surgical hand pieces according to claim 10 wherein the tube
with the larger distal opening has a single opening with a concave
shape and the tube with the other distal opening as a plurality of
small oval shaped openings.
12. A method of removing tissue or other objects from a patient by
phacoemulsification with an ultrasonic surgical hand piece having
at least a dual lumen vibrating work tip, comprising the steps of:
forming an incision in the patient; inserting a cylindrical cannula
in the incision, said cannula having a central opening; introducing
the work tip into opening in the cannula and bringing it into
contact with the tissue or object, said work tip having at least
first and second tubes aligned side by side and adjacent to each
other, the lumen of each of said first and second tubes being
separate and spaced apart, and each said tube having an opening at
its distal end through which the fluid received at or discharged
from the proximal end of the respective lumen of each said tube
exits from or enters the tube, with each said tube distal end
opening being separate, independent of, spaced from and without
being in communication with the distal end opening of the other
tube; turning on the hand piece so that the work tip vibrates at an
ultrasonic frequency and breaks up the tissue or object into small
pieces; circulating fluid in the cannula to cool it and protect the
tissue surrounding the incision from heat generated by the
vibrating work tip; extracting the small pieces of tissue or object
selectively through one of the at least dual lumens of the work
tip.
13. The method according to claim 12 further including the step of
injecting an infusion fluid into the patient through the other of
the dual lumens of the work tip.
14. The method according to claim 12 further including the step of
injecting an infusion fluid into the patient through channels in
the cannula.
15. The method according to claim 12 wherein the step of inserting
the cylindrical cannula in the incision involves the steps of:
providing a cylindrical cannula having a diameter about the size of
the incision, said cannula having a large flange on its proximal
end and a small flange or projections on its distal end; pushing
the distal end of the cannula into the incision so that the small
flange or projections pass into the patient and the large flange
comes to rest on the outer surface of the patient, whereby the
patient's about the incision is caught between the large flange and
the small flange or projections and the cannula is stabilized.
16. The method according to claim 14 wherein the step of injecting
an infusion fluid into the patient through channels in the cannula
comprises the steps of: providing a cannula with an internal
cylindrical channel, a connector leading to the cylindrical channel
and an exit; and connecting an infusion line to the connector so
that infusion fluid passes into the cylindrical channel and leaves
from the exit.
17. The method according to claim 16 in which the cannula exit is a
circular exit at the end of the cylindrical channel.
18. The method according to claim 16 in which the cannula exit is a
plurality of holes in a side wall of the cannula.
19. The method according to claim 12 in which the cannula is made
of TEFLON.RTM..
20. The method according to claim 12 wherein the tissue is a
cataract in the eye of the patient.
21. A cannula for use with an ultrasonic surgical hand piece with a
working tip that is vibrated at ultrasonic frequencies, comprising:
a cylindrical piece having a diameter about the size an incision; a
large flange located on the proximal end of the cylindrical piece,
said flange being significantly larger than the incision; a
projection located on the distal end of the cylindrical piece, said
projection being only slightly larger than the incision so that the
cannula can be passed through the incision by expanding it without
tearing the incision site; an internal cylindrical channel within
the cylindrical piece, a connector at the proximal end of the
cylindrical piece leading to the cylindrical channel; and an exit
from the cylindrical channel located beyond the projection toward
the distal end of the cylindrical channel.
22. The cannula of claim 21 wherein the projection is a series of
circumferential projections.
23. The cannula according to claim 21 wherein the projection is a
small circumferential flange.
24. The cannula according to claim 21 in which the cannula exit is
a circular exit at the end of the cylindrical channel.
25. The cannula according to claim 21 in which the cannula exit is
a plurality of holes in a side wall of the cylindrical piece.
26. The cannula according to claim 21 in which the cannula is made
of TEFLON.RTM..
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation-in-part of prior
U.S. patent application Ser. No. 12/215,315 filed on Jun. 26,
2008.
TECHNICAL FIELD
[0002] The present invention is generally directed to an ultrasonic
surgical hand piece with a dual lumen work tip that is disposable,
and an infusion cannula that can be used with the hand piece during
removal of cataracts from the eye of a patient by
phacoemulsification.
BACKGROUND OF THE INVENTION
[0003] The use of ultrasonic instruments in surgical applications
is well known. One widely used type of instrument is an ultrasonic
hand piece that is used in ophthalmic applications, such as in the
removal of cataracts from the eye by phacoemulsification.
[0004] FIG. 6 depicts one such type of prior art ultrasonic hand
piece as shown in U.S. Pat. No. 4,504,264 of Kelman. This hand
piece has a housing 10 of, for example, plastic or metal, within
which is supported a transducer means 11 for generating mechanical
vibrations upon excitation with an alternating-current electrical
signal. The transducer 11 is shown as a magnetostrictive transducer
with an electrical coil 12 wound about each leg of a stack of metal
laminations so that longitudinal mechanical vibrations are
produced. The transducer can also be of the piezoelectric type.
There is a connecting body 16 of, for example, titanium, having a
reduced diameter distal end portion, which also can be an attached
separate portion. The connecting body forms an acoustic impedance
transformer for conveying the longitudinal vibrations of the
transducer 11 for application to an operative tool or working tip
14 connected to the distal end of the connecting body 16.
[0005] The work tip 14 is at least partially external of the
housing 10. It is connected, such as by a screw thread, to the
narrowed distal end of the connecting body 16 so as to be coupled
to the transducer 11 so as to be longitudinally vibrated thereby.
The working tip 14 is an elongated, hollow tip of a suitable metal,
such as titanium, that is capable of supporting ultrasonic
vibrations. It has a distal end of a desired shape to be placed
against the tissue to be removed. The work tip 14 has a base
portion 15 in threaded engagement with the distal end of the
connecting body 16. The tip 14 can be interchanged by use of the
screw threads.
[0006] The distal end of the tip 14 is shown surrounded by a sleeve
17, which may be made of a material such as silicone, whose
proximal end 18 is supported in threaded engagement on a reduced
diameter end of the housing 10. If desired, the proximal end of
sleeve 17 can be engaged more proximally along the length of the
housing 10. The connecting body 16 has two elastomeric 0-rings 19,
20 on its outer surface. These provide a fluid-tight seal between
the connecting body 16 and the transducer means 11. A plurality of
screws 51 are shown disposed around the axis of the housing 10 for
preventing longitudinal displacement (other than vibration) or
rotational movement of the vibratory structure within the housing
and also for radial centering of the vibratory structure within the
housing. Other types of conventional mounting arrangements can be
used.
[0007] The hand piece also illustratively has electrical input
terminals 40, 41 for applying a suitable electrical signal to the
magnetostrictive transducer 11. Cooling water is shown provided
inside the housing 10 from an inlet 42 to an outlet 43 and within a
chamber between 0-ring 19 and a grommet 50 for circulation around
the transducer and connecting body. This is not always necessary
and is not used in most present day hand pieces.
[0008] The sleeve 17 around the tip 14 forms a first fluid passage
21 between the tip 14 and the sleeve for irrigation fluid. An inlet
22 is provided on the housing or sleeve distally of the 0-ring 20
for supplying the irrigation fluid to the passage 21 from a fluid
supply, e.g., a bag of saline solution (not shown).
[0009] A passage 23 is formed through the connecting body 16 that
is in communication with a central passage 25 of the work tip 14.
An outlet 24 on the housing or sleeve receives a suction
(aspiration) force that is applied to the passage 23 in the
connecting body and the central passage 25 in the work tip. A
chamber 31 is formed between the spaced 0-rings 19, 20 on the body
16 and the housing 10, with which the aspiration force from outline
24 communicates. Thus the aspiration force is from the source
(e.g., a suction pump not shown), into the chamber 31 between the
0-rings, through the passage 23 in the connecting body and the
passage 25 in the work tip 14. Tissue that is emulsified by the
work tip is aspirated from the operating site by the aspiration
flow force. In particular, saline solution introduced into the eye
through fluid passage 21 and tissue displaced by the vibration
force of the tip 14, is drawn into the distal end of passage 25 and
passes out of the hand piece through outlet 24. It should be noted
that passage 25 is located concentrically within passage 21.
[0010] As indicated, other apparatus (not shown) for use with the
hand piece include the suction pump for producing the aspiration
fluid (suction), the treatment fluid supply (irrigation fluid, such
as a saline liquid), an oscillator for applying an electrical
signal to the vibratory structure and control apparatus therefore.
All of these are of conventional construction.
[0011] Considering now the operation of the hand piece of FIG. 6.
When an electrical signal having a frequency of, for example,
40,000 cycles/second is applied to the coil 12 around the
magnetostrictive transducer 11, the transducer 11 vibrates
longitudinally at 40,000 cycles per second, thereby vibrating the
connecting bodies 13, 16 and the work tip 14. Treatment fluid is
supplied through inlet 22 and fluid passage 21 to bathe the tissue
in the operating site region around the working tip 14. Suction
force is applied through inlet 24 and passage 23 to the working tip
14 passage 25 to withdraw the tissue fragmented by the work tip
along with some of the treatment fluid.
[0012] Instruments of the type described above are often used in
cataract surgery in which the eye lens is removed from the eye
capsule and an intra-ocular lens (IOL) is then implanted. In such a
procedure before the IOL is implanted it has been found to be
desirable to cleanup lens substance and lens epithelial cells
(LEC's) in the capsular bag and to remove them. Doing this
procedure provides a more stable and long-term fixation for certain
types of IOL's in the capsular bag. One manner of accomplishing the
cleanup is to use a combination of irrigation of the capsular bag
interior with a liquid together with the application of low power
ultrasonic energy. This dislodges the unwanted cells and substances
so that they can be removed from the capsular bag by the aspiration
fluid flow.
[0013] In a cleanup procedure it is advantageous if the flow of the
irrigation liquid can be made more directional than would be
possible using the hand piece with the outer sleeve through which
the liquid flows and exits from around the work tip that produces
the ultrasonic energy. It is also better if the aspiration force is
lower. As a result, typically a different tip from the one
illustrated in FIG. 6, which breaks up the tissue, is used for the
cleanup. Thus, the surgeon must remove the first work tip and place
a new work tip in the eye. This second insertion into the eye
increases the possibilities of infection and trauma. In an
alternative prior art embodiment it is possible to use a separate
lumen or probe that conveys only the irrigation liquid and a
separate probe with a work tip. However, this has a disadvantage in
that the surgeon would have to keep inserting and withdrawing the
ultrasonic work tip and irrigation probe from the eye. As a result,
this would also subject the patient to the increased possibilities
of infection and trauma.
[0014] As shown in the present inventor's own U.S. Pat. No.
7,083,589, the surgical instrument may be provided with a coupler
body located between the connecting body and the work tip. In such
a case the aspiration fluid flow is provided from the work tip
aspiration passage through the coupler to an outlet without coming
into contact with the interior of the connecting body. Irrigation
fluid can be provided through a portion of the housing that
surrounds the proximal part of the work tip so as to form a chamber
which is in communication with a separate passage in the work tip.
The coupler is detachably connected to the connecting body. This
allows the removal of the work tip, which becomes a single use
part, so that the rest of the instrument can be reused by replacing
the work tip without having to sterilize the connecting body.
However, the portion of the housing surrounding the work tip and
which forms the chamber for irrigation fluid, also needs to be
replaced in this design.
[0015] Accordingly a need exists for a surgical hand piece that can
provide both ultrasonic energy to emulsify tissue, cells and other
substances which are aspirated by an aspiration fluid and an
irrigation liquid that can be applied to part of the operating site
being cleaned in a more directional and controlled manner. Further,
it would be beneficial if the work tip were made replaceable in a
more convenient manner, e.g., without having to replace part of the
housing.
SUMMARY OF THE INVENTION
[0016] In accordance with the invention a surgical hand piece is
provided that can perform all of the functions of emulsification of
tissue and other substances by ultrasonic energy, aspiration of
such tissue and substances, and also provide a more directed liquid
irrigation of a site that is being worked on in order to clean up
the site.
[0017] The invention provides a surgical hand piece that has a
novel work tip having a dual separate side-by-side lumen
construction, as opposed to the concentric structure of the prior
art. The work tip is effectively a unit of two tubes or sections of
two tubes. Hereafter the term "tube" refers to a full tube or a
section of a tube with each such tube or section having its own
lumen. Where sections of tubes are used at least a portion of such
sections are integrated along a common surface. One of the tubes
receives the ultrasonic energy from the hand piece and its lumen
forms the aspiration passage through which the emulsified tissue
and other substances are removed. This tube can have any desired
shape at its working end and any desired shape of aspiration
opening. The irrigation liquid flows through the other tube and its
end can have any number of openings or ports in any desired pattern
to direct the flow of the irrigation fluid.
[0018] The novel work tip, whose lumens allow fluid to flow from
proximal to distal ends and vice versa, permits switching of the
tubes between aspiration and irrigation functions so that the
surgeon has a work tip with different types of openings for both
irrigation and aspiration functions. In different embodiments of
the invention, both of the tubes of the work tip can be supplied
with ultrasonic energy and either one used for aspiration or
irrigation. Further, the tip may be designed so that it can be
easily exchanged for a new tip and the hand piece put into service
again without having to sterilize it.
[0019] The hand piece of the invention has numerous advantages. For
example, the need for infusion sleeves within which the irrigation
liquid flows is eliminated. An infusion sleeve is a separate item
that needs to be attached to the instrument hand piece. This means
that such sleeves have to be designed and manufactured for a
particular hand piece. Also, the sleeves are subject to wear and
tear and other complications. The elimination of the need for an
infusion sleeve from the surgical hand piece has economic
advantages in that there are fewer parts to deal with. The hand
piece of the present invention also has a surgical benefit in that
it eliminates the need for the surgeon to remove a work tip from
the operating site, such as the eye, and to insert a separate work
tip or tips having irrigation/aspiration (1/A) capability, in order
to perform special procedures, such as cortical and lens epithelial
cleanup.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The foregoing and other objects and advantage of the present
invention will become more apparent upon reference to the following
specification and annexed drawings in which:
[0021] FIG. 1 is a plan view, partly in cross section, of one
embodiment of the surgical hand piece of the invention;
[0022] FIG. 1A is a plan view, partly in cross section, of another
embodiment of the surgical hand piece of the invention;
[0023] FIG. 2 is an enlarged view of the distal end of the work tip
shown in FIG. 1;
[0024] FIGS. 3A, 3B, 3C and 3D are cross-sectional views showing
various forms of integrated work tips;
[0025] FIGS. 4A and 4B are schematic views of a valve arrangement
to control switching between irrigation and aspiration functions
for the tubes of the work tip;
[0026] FIG. 5 is a view, partly in cross-section, of another
embodiment of surgical hand piece according to the present
invention;
[0027] FIG. 6 is a view in cross-section of a prior art type of
surgical hand piece;
[0028] FIG. 7 is a schematic view of a modification of the work tip
according to the present invention;
[0029] FIG. 8 is a schematic side view of the eye showing a cannula
located in the cornea and a dual lumen work tip positioned to enter
the cannula;
[0030] FIG. 9 is a top view of the cannula of FIG. 8;
[0031] FIG. 10 is an enlarged cross sectional view of the cannula
positioned in the cornea and receiving auxiliary infusion fluid
which passes through it and into the eye;
[0032] FIGS. 11A and 11B show alternative auxiliary infusion fluid
flow paths in the cannula of FIG. 8; and
[0033] FIG. 12 is a plan view, partly in cross section, of a
further embodiment of the surgical hand piece of the invention in
which only the work tip and connecting body liners need to be
replaced after use.
DETAILED DESCRIPTION OF THE INVENTION
[0034] FIG. 1 shows a first embodiment of the hand piece of the
invention. It uses a number of the components of the prior art type
of hand piece described above with respect to FIG. 6. The source of
the electro-mechanical energy is shown schematically by reference
number 102 and can be either the electromagnetic type as described
or the piezoelectric type. It is preferred, and is conventional,
that the output power of the source 102 can be controllably varied
to set the ultrasonic power at the work tip distal end.
[0035] Connected to the source 102 is the connecting body 104
within a housing 108. A pair of 0-rings 112 and 114 spaced apart
around the connecting body 104 and engaging the inner surface of
the housing form a first chamber 118. The first chamber 118
receives aspiration force from a line 124 that is connected to a
suitable source such as a peristaltic pump. It is preferred that
the negative (suction) pressure provided at line 124, be
controllable. A flow passage 120 is formed in the connecting body
104 that communicates with the first chamber 118 and extends to the
reduced diameter distal end of the connecting body 104.
[0036] A second chamber 158 is formed between the 0-ring 112 and
the distal end of the housing 108. This chamber receives irrigation
fluid from a line 164 that is connected to a suitable source, such
as a bag of saline solution or a liquid supply having a pump. Here
also, it is preferred that the volume and pressure of the fluid be
controllable. The proximal end of a work tip 130 extends through
the distal end of the housing 108. A flange hub 152 is connected to
an intermediate point of the work tip and the flange abuts against
the distal end of the housing 108 and is held against it by a
threaded collar 154. This forms a fluid tight seal at the distal
end of the housing and seals the second chamber 158.
[0037] The work tip 130 is a unit of two tubes or tubular sections
132 and 134. The two tubes can be of any of the types
illustratively shown in FIGS. 3A-3D and described below. As
illustratively shown, the proximal end of the work tip 130 first
tube 132 has a coupling 138 that is threaded into the distal end of
the connecting body 104. This places the lumen of the first tube
132 in communication with the passage 120 in the connecting body
104. The tube 132 will also be provided with ultrasonic energy from
the source 102 through the connecting body 104. At the proximal end
of the work tip 130 there is a second tube 134, which is open,
located in the housing second chamber 158 and in communication with
any fluid in this chamber. With this arrangement, there is fluid
flow to or from each of the tubes 132 and 134 of the integrated
work tip 130. That is, aspiration, flow or liquid flow can be
provided from the distal end of the first tube 132 through the
passage 120 in the connecting body 104, into the first chamber 118
so as to exit at line 124 under suction from the aspiration pump.
Similarly, irrigation fluid flow can be provided to line 164, to
the second housing chamber 158, to the proximal end of the second
tube 134 to exit at the distal end of tube 134.
[0038] FIG. 1A shows a further embodiment in which there is no flow
passage in the connecting body 104. Here, the proximal end of the
work tip 130 is a generally cylindrical hub 135 that receives the
proximal ends of the tubes 132 and 134. The tubes can be any of the
types described below with respect to FIGS. 3A-30. The proximal end
of the hub 135 is of reduced diameter so that it can be attached
such as by threads 138 with threads in a recess of the distal end
of the connecting body 104 whose proximal end is connected to the
source of ultrasonic energy 102. The hub 135 has respective
passages 224 and 264 to the lumen of each of the tubes 132 and 134.
The aspiration and irrigation fluids are withdrawn or supplied,
respectively, over the lines 124 and 164 through the hub passages
directly to the lumens of the two tubes. The lines 124 and 164 can
be inserted directly into the hub passages 224 and 264. A housing
128 (shown in dotted line) of a suitable shape is provided over the
energy source 102 and the connecting body 104. In this embodiment,
both tubes 132, 134 receive the ultrasonic energy. As described
below, the fluids withdrawn from or supplied to the two tubes can
be switched by using a control valve.
[0039] The work tip of FIG. 1A has an advantage in that there is no
fluid flow through the connecting body 104 or any part of the
instrument other than the hub 135 and work tip 130 itself.
Therefore, they are the only parts of the instrument that can
become contaminated if the patient being operated on has a malady
such as "mad cow/prion" disease. Also, with this arrangement, while
the housing may extend over the energy source 102 and the
connecting body 104, it need not extend over the hub 135. Thus no
fluid chamber is formed by the housing which needs to be exchanged
after use. Only the work tip 130 and hub 135 have to be sterilized
after each use of the instrument or they can be treated as
"disposable" and a new work tip and hub can installed each time
that the instrument is used. In order to make the disposability of
the work tip more practical, it can be made, at least in part, of
less expensive materials. For example, a core portion 260 of the
hub (shown in dotted line) from connecting body 104 to the tubes
132, 134 and the tubes themselves may need to be made of a very
hard material, e.g., titanium, in order to transmit vibrations of
sufficient strength to affect the breakup of a cataract during its
removal. However, a portion of the hub surrounding the core, the
passages 224, 264 and the connectors 124, 164 may be made of a less
expensive material, e.g., a hard plastic, in order to reduce its
cost.
[0040] FIG. 2 shows an illustrative example of the distal ends of
the two tubes 132 and 134 of the work tip 130. The proximal ends of
the tubes are disposed as shown in FIG. 1 or the inverse of what is
shown in FIG. 1A or in another embodiment as shown in FIG. 5, or by
any suitable arrangement such that ultrasonic energy from the
transducer and aspiration fluid is coupled to the proximal end of
at least one of the tubes and the proximal end of at least one tube
can receive the irrigation fluid from its distal end. In this
example the first tube 132 is intended to be connected to receive
the ultrasonic energy from the source 102 and has a scooped, or
concave shaped, opening 162 near its distal end to receive the
emulsified tissue that is produced by vibrations of the free end of
the tube. The opening 162 can be of any desired shape and size and
also can be at the extreme distal end of the tube. The second tube
134 has at least one and preferably a plurality of openings 165
through which an irrigation liquid can flow to exit at the
operating site. The number of openings 165 and their pattern can be
selected as desired. There can be one or more rows along the tube
length. The openings 165 in tube 134 preferably are oval
(elliptical) in shape as shown. Oval shaped openings 165 allow for
both good dispersion of the irrigation fluid and a large area for
aspiration of cells and substances dislodged by the irrigation
liquid. The openings 165 also can have the standard circular hole
configuration. As explained below, the hand piece of the invention
provides for switching of the functions to be performed by the two
tubes. That is, either tube can be used to perform the irrigation
function or the aspiration function.
[0041] FIGS. 3A, 3B, 3C and 3D show cross-sections of tubes that
can be used for the work tip 130. In FIG. 3A two fully circular
tubes 132a and 134a are joined together at the area 135, such as by
welding, to form a unitary structure. The joining 135 can be
continuous or spaced along the lengths of the two tubes. When two
complete tubes are used for the work tip they do not necessarily
have to be connected together along their lengths as shown in FIG.
3A since each tube has its own lumen and does not need any part in
common with the other tube to have fluid flow therein. An
arrangement of two separate tubes 132b and 134b is shown in FIG.
3B. A unitary structure work tip is formed by using a hub or a
similar element to hold the two tubes together as shown in FIGS. 1,
1A and FIG. 5.
[0042] In FIG. 3C two half tube sections 132c and 134c are
connected to a common central wall 137 to form a unitary structure.
Here an overall somewhat elliptical tube can be divided into the
two tube sections and then joined to the center common wall 137. In
FIG. 3D there is a fully circular tube 134d on top of which a part
of a circular tube section 132d is joined at 139 along its length,
making the work tip a unitary structure. When two tube sections are
used to form the work tip the proximal ends are modified (not
shown) to have the appropriate shape, such as fully circular, so as
to be able to perform its function such as coupling to the
connecting body to receive ultrasonic energy and to receive
aspiration and irrigation fluid. The distal ends also are modified
to provide fluid flow from and to the aspiration and irrigation
openings.
[0043] It should be understood that the two tubes 132 and 134 can
be of different diameters and shapes in addition to the more
symmetrical arrangements shown in the drawings. Also, the tubes can
be made of any suitable material, such as titanium or any suitable
material which can withstand the stress of vibration. Both tubes
can be of the same material, or they can be of different materials.
It also may be desirable to make one of the tubes, for example the
one to which the irrigation fluid is usually applied, of a plastic
material such as TEFLON.RTM.. While a tube of plastic material will
not be able to vibrate if it receives ultrasonic energy, it can
still be used to perform both the aspiration and irrigation
functions depending upon which fluid is supplied to it. Further,
the two tubes 132 and 134 can be of different lengths.
[0044] FIGS. 4A and 4B schematically show a valve arrangement for
the supply lines 124 and 164. There is a valve 175 that receives
one input from an irrigation liquid source, such as a bag of a
saline solution using gravity feed or from a liquid source under
controlled pressure and volume. The valve second input is from an
aspiration source, such as a peristaltic pump, of controlled
suction force or pressure. In FIG. 4A the valve 175 is in a
position such that there is irrigation liquid flow is to line 164
meaning that there will be liquid in the second housing chamber 158
of FIG. 1 to be provided to the second tube 134 to flow out of its
distal end. The aspiration source will be connected to the line 124
so that there will be negative pressure (suction) fluid in the
first housing chamber 118 that is provided to the distal end of the
first tube 132 through the passage 120 in the connecting body 104.
Thus, fluid will flow from the distal end of tube 132 out of line
124 to the valve and then to the suction pump. As seen in FIG. 4B,
by switching the valve 175 the conditions will be reversed so that
there will be aspiration flow on line 164 causing the second tube
134 to perform an aspirating function and liquid flow in line 164
causing the first tube 132 to perform an irrigation function. Thus,
the tubes 132, 134 are capable of fluid flow in either direction,
depending on the function they are performing.
[0045] FIG. 5 shows another embodiment of the invention for
coupling the work tip 130 to the hand piece. The same reference
numbers are used for the same components of FIG. 1. Here there are
two passages 120 and 180 in a connecting body 204. One end, the
proximal end, of passage 120 is in communication with the
irrigation fluid input of the supply line 124. The proximal end of
passage 180 is in communication with the aspiration fluid of the
supply line 164. The distal ends of the two passages 120 and 180
terminate at the distal end of the connecting body 204.
[0046] There are threads 182 around the connecting body distal end.
A hub 190 is around the proximal ends of the work tip tubes 132 and
134 which are bent so that the proximal ends of their lumens are
parallel to the distal ends of the connecting body passages 120 and
180. A collar 194 with internal threads on its open end has its
flange end rotatably mounted in a groove 192 in the hub 190. There
are mating index pieces, such as mating grooves and ribs or pins
(not shown), on the opposing faces of the connecting body 204
distal end and the hub 190 so that the proximal end of the lumen of
tube 132 will be aligned with the distal end of connecting body
passage 120 and the proximal end of the lumen of tube 134 aligned
with the distal end of passage 180. Other types of alignment pieces
and markings can be used. When the tubes and connecting body are
properly aligned the collar 194 is tightened on the connecting body
threads 182 and the lumens at the proximal ends of tubes 132 and
134 will be brought into fluid communication with the distal ends
of the connecting body passages 120 and 180. 0-rings 193 are
provided in the connecting body at the distal ends of passages 120
and 180 to make the communication fluid tight.
[0047] In this embodiment of the invention, both of the tubes 132,
134 receive the ultrasonic energy from the source 102. The valve
175 of FIG. 4 can be used with the hand piece of FIG. 5 to switch
the fluid flow from the sources 124 and 164 to the lumens of tubes
132 and 134 of the integrated work tip. Since both tubes 132 and
134 receive ultrasonic energy the emulsification of tissue and its
aspiration can take place through either one in addition to each
tube being able to supply irrigation liquid through the different
types and shapes of openings at the distal ends of the tubes.
[0048] A still further embodiment of a work tip for a hand piece
according to the present invention is shown in FIG. 12. As seen in
FIG. 12 the connecting body 204 has passages 120, 180 as in the
embodiment of FIG. 5. However, in FIG. 12 the connecting body has a
narrow section 205 on which there are the threads 182. Tubes 132
and 134 abut this narrow section of the connecting body. A threaded
collar 195 is slide over the tubes and engages the threads 182. The
narrow portion 205 of the connecting body and the tubes have
alignment pieces (not shown) so that passages 120, 180 are aligned
with the lumens in the tubes 132, 134. Further, the tubes 132, 134
have proximal flanges that fits within the collar 195 so that when
the collar is tightened onto the threads 182 of the narrow part 205
of the connecting body, a tight stable connection is made between
the tubes and body.
[0049] Plastic disposable tubes 324, 364 are provided. These
disposable tubes can be inserted into the passages 120, 180 until
their distal ends enter the two work tip tubes 132, 134. As a
result, the tubes are made of a flexible material so that they can
bend along the passages 120, 180. The proximal ends of tubes 132,
134 have O-rings or other sealing type openings which are made of a
material softer than the disposable tubes so that these tubes can
push through the seals into the tubes 132, 134 and form a fluid
tight connection with them. Such seals can be of the type shown in
FIG. 5, except they are located in the tubes 132, 134, instead of
the connecting piece 204. The ends of the disposable tubes have
connector 325, 365 at their proximal ends for connection to the
source of irrigation fluid or aspiration vacuum.
[0050] When the hand piece is used in its intended fashion and the
procedure is over, the hand pieces can be quickly readied for use
on another patient without the need for sterilization. In
particular, the collar 195 is loosened. Then the working tip with
tubes 132, 134 is disposed of. In addition, tubes 324, 364 are also
disposed of. Each of these sets of tubes is replaced with clean,
pre-sterilized tubes, and the hand piece is ready for the next use.
This is possible because the only parts of the hand piece that come
into contact with the aspiration fluid from the patient are the
interiors of the tubes 132, 134 and 324, 364. As noted with respect
to the embodiment of FIG. 5, it may be useful in terms of expense
to make the tubes 132, 134 of a material that is hard, but not as
expensive as titanium, so as to be able to transmit the vibration
force. The tubes 324, 364 do not have to transmit the vibration
force, so they can readily be made of a plastic material such as
TEFLON.RTM., as a way of reducing the cost of the disposable parts
of the hand piece.
[0051] The work tips of the invention, such as illustratively shown
in FIGS. 1, 1A, 5 and 12, can be used with only an
irrigation/aspiration (1/A) function. That is, the source of
ultrasonic energy can be turned off and only the aspiration and
irrigation fluids supplied to the tubes 132 and 134. Also, the
aspiration force is lowered, e.g., from 500 mm Hg to 5-10 mm Hg
during the cleaning operation so that the posterior capsule tissue
at the back of the eye is not drawn into the tube. Here also the
valve arrangement of FIG. 4 can be used so that either of the tubes
can receive aspirated tissue or supply irrigation fluid. However,
it may be preferable to utilize the tube with the small circular
holes 165 for this cleaning procedure, again to avoid aspirating
the posterior capsule tissue. Thus, the same instrument can be used
for the phacoemulsification function while performing irrigation
and aspiration as an operation takes place and also only for I/A
functions (no ultrasonic energy is used) useful for cleaning the
capsular bag as described above. This eliminates the need for the
surgeon changing instruments and also provides the surgeon with a
working tip having two tubes with different shape openings
available for both aspiration and irrigation.
[0052] Following the above, only one of the tubes can be used only
as an I/A working tip. That is, it does not receive ultrasonic
energy. This is shown in FIG. 7 in which the tube 234 follows the
general format of the tube 134 of FIG. 2. That is, it has the oval
openings 165 along the tube length. It receives either irrigation
or aspiration fluid from sources 210 and 212 at its proximal end
through a valve 275. The tube 234 can be used alone in the eye
capsular bag for the substance and cell cleanup procedure described
above. The oval shaped openings 165 allow for both good dispersion
of the irrigation fluid and a large area for aspiration of cells
and substances dislodged by the irrigation liquid.
[0053] In each of the embodiments described a support member can be
mounted around the work tip 130 to rest against the eye when the
work tip is inserted in the eye. For example, a cannula can be
inserted into the incision site and then the work tip 130 can be
placed into the cannula. This cannula provides thermal insulation
at the incision sight in order to protect the eye from any heat
generated by the vibration of work tip 130. This arrangement is
shown in FIG. 8.
[0054] As noted above, FIG. 1A illustrates a surgical hand piece
with a single use work tip 130. FIG. 8 is a schematic side view of
the eye 300 of a patient showing the dual lumen work tip 130 (not
to scale) positioned to enter a surgical opening made in the cornea
302 of the eye during a procedure to remove cataracts 304 from the
eye by phacoemulsification. The work tip enters the eye through a
cannula 310 adapted to fit in the opening. Once in the vicinity of
the cataract, the ultrasonic vibration of the work tip 130 causes
the cataract to break up into small pieces which can be aspirated
through one of the tubes 132, 134. In addition to the pieces of
cataract, some of the fluid in the eye is also removed during the
aspiration. If too much fluid is removed, the cornea can collapse,
complicating the procedure and possibly damaging the eye. As noted
above, fluid can be replaced by injecting it into the other tube of
the work piece.
[0055] The cannula is generally cylindrical in shape. As best seen
in the top view of FIG. 9, the cannula has a large outer flange 311
which keeps it from completely entering the eye. Also, it has a
small flange or protrusions 313 on the part adjacent the interior
surface of the cornea in order to anchor the cannula in place
between the two flanges. These small protrusions or flanges are
located circumferentially around the cylindrical shape and must not
be too large because they are pressed into the opening in the
cornea and stretch it slightly as they enter the eye. However, they
do not stretch it so much that it damages the corneal tissue
surrounding the opening.
[0056] The housing 128 for the surgical piece as shown in FIG. 1A,
as is also depicted in FIGS. 8 and 10. Housing 128 covers the
source of the electro-mechanical energy 102 and the connecting body
104. However, the work tip 130 is not within the housing, which
facilitates easy exchange of work tips. As a result, the
ultrasonically vibrating work tip 130 is exposed. The cannula 310
protects the corneal tissue surrounding the opening from friction
caused by this vibration. In order to assist in friction reduction
the cannula can be made of a low friction material such as
TEFLON.RTM..
[0057] In order to further protect the cornea from the heat
generated by friction from the vibrating work piece, the cannula
can be provided with cooling fluid as shown in FIG. 8 and in more
detail in enlarged FIG. 10. The cannula 310 can be connected to an
infusion line 400. Within the cannula there is a cylindrical
channel 314 so that the fluid from line 400 completely surrounds
the interior of the cannula and cools its outer surface, which
engages the cornea 302. The fluid can exit the cannula within the
eye as auxiliary irrigation fluid though a circular exit 315 as
best shown in FIG. 11A. However, as an alternative or in addition
to the circular exit 315 there may be provided a series of holes
318 as shown in FIG. 11B.
[0058] If the infusion fluid from the work tip 130 is too little,
it can be compensated for by the auxiliary fluid infused through
the cannula. If the amount is too much, either because of the work
tip and/or the cannula, the central opening in the cannula through
which the work tip extends is sufficiently wide that the work tip
does not block it and the extra fluid can pass out of the eye
around the work tip.
[0059] While the invention has been shown and described in
connection with the removal of cataract from the eye of a patient,
the apparatus and method may also be used for other types of
surgery in other parts of the body, e.g., the removal of
neurological tissue.
[0060] Specific features of the invention are shown in one or more
of the drawings for convenience only, as each feature may be
combined with other features in accordance with the invention.
Alternative embodiments will be recognized by those skilled in the
art and are intended to be included within the scope of the claims.
Accordingly, the above description should be construed as
illustrating and not limiting the scope of the invention. All such
obvious changes and modifications are within the patented scope of
the appended claims.
* * * * *